The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital

About this trial

Postherpetic neuralgia (PHN) is the most common complication of herpes zoster (HZ) and represents a major clinical challenge due to its chronicity and impact on quality of life. Current treatments for acute HZ pain have limited efficacy in preventing PHN, highlighting the need for effective preventive strategies targeting early pathophysiological mechanisms. Venlafaxine as a plausible and clinically relevant candidate for early intervention to prevent the transition from acute HZ pain to PHN.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Ages more than 18 years;

2. Patients with onset of HZ rash less than 30 days;

3. Experiencing moderate to severe HZ pain with an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0 = no pain, 10 = worst possible pain);

4. Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;

Disqualifiers

1. HZ with head, neck, ocular, mucous membrane, cranial nerve, or central nervous system involvement or generalized HZ;

2.Known hypersensitivity to venlafaxine;

3. Previous antiviral treatment that did not comply with guideline recommendations;

4. History of herpes zoster vaccination before enrollment;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Venlafaxine combined conventional therapy

    Drug

    Venlafaxine will be initiated at 75 mg once daily and titrated based on pain response and tolerability before 90 days after rash onset. All participants will receive standardized analgesic management following the World Health Organization pain ladder. In addition, the group will contain conventional treatment for HZ, including NSAIDs, opioids, antiviral drugs and so on. After 90 days from rash onset, treatment will be standardized across both groups. Participants who develop persistent pain consistent with PHN will receive guideline-based management, including gabapentinoids, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, and topical agents such as lidocaine or capsaicin, as clinically indicated.

  • Conventional therapy

    Drug

    The control group will receive conventional therapy alone before 90 days after rash onset. After 90 days from rash onset, treatment will be standardized across both groups. Participants who develop persistent pain consistent with PHN will receive guideline-based management, including gabapentinoids, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, and topical agents such as lidocaine or capsaicin, as clinically indicated.

Treatment groups

832 Participants
are divided into 2 treatment groups
Group A: Venlafaxine combined with conventional therapy groupExperimental treatment 1 intervention
Group B: Conventional therapy groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of PHN

PHN will be defined as persistent pain in the affected dermatome at 90 days after rash onset that is clinically meaningful, operationalized as an average pain score ≥ 3 on the NRS.

Time frame
at 90 days after rash onset

Secondary outcomes

1

The average daily pain intensity

The numeric rating scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain. A higher score indicates more severe pain.

Time frame
at weeks 1, 2, 4, 8, 12, 24, and 52
2

The worst numeric rating scale score

The numeric rating scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain. A higher score indicates more severe pain.

Time frame
at weeks 1, 2, 4, 8, 12, 24, and 52
3

Proportion of Patients Achieving Pain Reduction

The proportion of patients achieving a ≥ 50% and ≥ 30% reduction in mean baseline pain intensity

Time frame
at weeks 1, 2, 4, 8, 12, 24, and 52
4

Average weekly consumption of each analgesic class

Time frame
at weeks 4, 8, 12, 24, and 52

Other outcomes

Sponsors and contacts

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Beijing Tiantan Hospital

Lead sponsor

Xiangya Hospital of Central South University

Collaborator

Zhongnan Hospital

Collaborator

Jilin Provincial People's Hospital

Collaborator